Optical Coherence Tomography of the Middle Ear Using Ossiview

Middle Ear Disease Clinical Trial

Official title:

Optical Coherence Tomography of the Middle Ear Using Ossiview

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05085379
• Other study ID #: 262886
• Status: Withdrawn
• Start date: November 2, 2023
• Est. completion date: November 2, 2023

Study information

• Verified date: March 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to understand the diagnostic applications for this imaging technology and identify particular disorders to target for future clinical investigations. Images obtained with the Ossiview device will be correlated to other standard of care (SoC) testing including microscopic otoscopy, CT scans, MRIs, audiologic testing results, and surgical and pathology reports.

Description:

Optical Coherence Tomography (OCT) is an optical imaging technique that uses a low-coherence interferometer to produce depth-resolved scans in tissue. This study will explore the utility of this technology in otology patients presenting with various pathologies as well as normal subjects.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age =18 years
• Ability to understand the consent process with adequate language and cognitive communication ability
• Presence of one of the pathologies (either currently or in the past) above or healthy control Exclusion Criteria
• Narrow or stenotic external meatus (ear canal)
• Movement disorder causing inability to keep head still during imaging

Related Conditions & MeSH terms

• Ear Diseases
• Middle Ear Disease

Intervention

Device:
• Ossiview
Imaging of the ear using Optical Coherence Tomography

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic correlation with microscopic otoscopy	Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy	6 months
Primary	Diagnostic correlation with CT scans	Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans	6 months
Primary	Diagnostic correlation with Magnetic Resonance Imaging (MRI)s	Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs	6 months
Primary	Diagnostic correlation with audiologic testing results	Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results	6 months
Primary	Diagnostic correlation with surgical reports	Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports	6 months
Primary	Diagnostic correlation with pathology reports	Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports	6 months